Mitomycin Injection Recalled Due to Lack of Sterility Assurance
Vital Care Compounder is recalling 185 syringes of Mitomycin Injection due to lack of sterility assurance discovered during FDA inspection. The product cannot guarantee sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect affecting sterility assurance in an injectable medication. Although no illnesses or injuries have been reported, the product represents a risk-of-harm to patients, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vital Care Compounder is recalling Mitomycin Injection 0.375 mg/mL in 1 mL syringes due to a manufacturing defect. A total of 185 syringes have been recalled.
During an FDA inspection, the agency found that the recalled products were produced in a manner that cannot guarantee their sterility. Sterility is critical for injectable medications, as non-sterile injections could introduce harmful pathogens directly into the patient's bloodstream.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. The affected lot numbers are 60618 (beyond-use date 5/6/2023) and 66536 (beyond-use date 7/8/2023).
Patients who received this medication should contact their healthcare provider immediately. Healthcare providers and pharmacies should remove this product from dispensing and consult with the FDA regarding proper handling and return of recalled units.
The recalled product
- Product
- MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Oncology Injectable
- Affected units
- 185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: 60618
- BUD: 5/6/2023
- 66536
- BUD: 7/8/2023
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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